Regulator resource library

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Medicine Shortagesdiscontinuations Electronic Notification Form

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Applying USE Restricted Representation

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Changes Propolis AND Royal Jelly Listed Medicine Applications

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Completing Biowaiver Templates

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Completing Bioequivalence Study Information Form

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Registered Complementary AND OTC Medicines Application AND Submissions

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GMP Clearance Code Tables

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Evaluation Substances USE Listed Medicines AND Assessed Listed Medicines User Guide

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Creating Consumer Medicine Information CMI Summary Page User Guide Sponsors

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Consumer Medicine Information CMI HOW USE Improved CMI Template

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Publication Notified Medicine Shortages Updated Protocol

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Changing Sponsor Details Product Information PI AND Labels Prescription Medicines

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Changing Sponsor Details PI AND Labels

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Ectd Baseline Sequences

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Ectd Withdrawals

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Authorised Prescriber Online System

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Special Access Scheme SAS Online System

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Completing Application Consent Import Supply OR Export Medical Devices DO NOT Meet Essential Principles

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Authorised Prescriber AP Applications Quick Reference Guide

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Special Access Scheme SAS Applications Quick Reference Guide

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Sponsor SIX Monthly Report Supply Unapproved Therapeutic Goods

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Register Small Business TGA

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EPA Rich Nannochloropsis Oculata OIL

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Sponsor SIX Monthly Reporting Form

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Leptospermum Scoparium OIL

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Notification Commencement Supply

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Guideline Clinical Investigation Medicinal Products Treatment Gout

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Guideline NON Clinical Documentation Mixed Marketing Authorisation Applications

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ICH Topic S 7B Nonclinical Evaluation Potential Delayed Ventricular Repolarization QT Interval Prolongation Human Pharmaceuticals

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ICH Topic Q 3 R2 Impurities NEW Drug Substances

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Note Guidance Clinical Investigation Medicinal Products Treatment AND Prevention Bipolar Disorder

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Points Consider NON Clinical Assessment Carcinogenic Potential Insulin Analogues

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Note Guidance Carcinogenic Potential

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Guideline Strategies Identify AND Mitigate Risks First Human Clinical Trials Investigational Medicinal Products

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Guideline Data Monitoring Committees

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Points Consider Need Assessment Reproductive Toxicity Human Insulin Analogues

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Note Guidance USE Stability Testing Human Medicinal Products

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Guideline Clinical Evaluation Medicinal Products Intended Treatment Hepatitis B

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Guideline Clinical Investigation Medicinal Products Prophylaxis Venous Thromboembolic Risk NON Surgical Patients

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Guideline Clinical Development Medicinal Products Treatment HIV Infection

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Note Guidance Clinical Investigation Medicinal Products Treatment Peripheral Arterial Occlusive Disease

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Guideline Clinical Investigation Medicinal Products Used Treatment Osteoarthritis

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Guideline Clinical Investigation Medicinal Products Treatment Epileptic Disorders

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Guideline Clinical Investigation Medicinal Products Treatment Amyotrophic Lateral Sclerosis ALS

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Guideline Clinical Evaluation Medicinal Products Used Weight Control Cpmpewp28196 REV 1

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Guideline Clinical Investigation Steroid Contraceptives Women

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Guideline Evaluation Medicinal Products Treatment Primary Osteoporosis

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Guideline Evaluation Medicinal Products Indicated Treatment Bacterial Infections

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Points Consider Clinical Investigation Medicinal Products Treatment Acute Stroke

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Guideline Reporting Physiologically Based Pharmacokinetic Pbpk Modelling AND Simulation

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Guideline Setting Specifications Related Impurities Antibiotics

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Guideline Clinical Investigation Medicinal Products Treatment Rheumatoid Arthritis

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Guideline Evaluation Medicinal Products Treatment Irritable Bowel Syndrome

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Guideline Clinical Investigation NEW Medicinal Products Treatment Acute Coronary Syndrome

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ICH Guideline Q4B Annex 8 Evaluation AND Recommendation Pharmacopoeial Texts USE ICH Regions Sterility Test General Chapter

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Guideline Clinical Investigation Medicinal Products Treatment Migraine

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ICH Guideline Q8 R2 Pharmaceutical Development

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Guideline USE Near Infrared Spectroscopy Pharmaceutical Industry AND Data Requirements NEW Submissions AND Variations

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ICH Topic S 1 Need Carcinogenicity Studies Pharmaceuticals

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Guideline Scientific Data Requirements Vaccine Antigen Master File Vamf

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ICH Topic E 14 Clinical Evaluation Qtqtc Interval Prolongation AND Proarrhythmic Potential NON Antiarrhythmic Drugs

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ICH Guideline Q4B Annex 6 Note Evaluation AND Recommendation Pharmacopoeial Texts USE ICH Regions Uniformity Dosage Units General Chapter

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ICH Considerations Oncolytic Viruses

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ICH Topic E7 Studies Support Special Populations Geriatrics Questions AND Answers

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ICH Topic E 5 R1 Questions AND Answers Ethnic Factors Acceptability Foreign Clinical Data

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ICH Guideline Q10 Pharmaceutical Quality System

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ICH Topic Q 5 E Comparability Biotechnological Biological Products

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ICH Guideline Q4B Annex 1 Evaluation AND Recommendation Pharmacopoeial Texts USE ICH Regions Residue Ignitionsulphated ASH

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ICH Guideline Q9 Quality Risk Management

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ICH Topic E 2 E Pharmacovigilance Planning PVP

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ICH Guideline Q8 Q9 AND Q10 Questions AND Answers Volume 4

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ICH Guideline Q4B Annex 3 Evaluation AND Recommendation Pharmacopoeial Texts USE ICH Regions Test Particulate Contamination SUB Visible Particles General Chapter

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ICH Guideline Q4B Annex 2 Evaluation AND Recommendation Pharmacopoeial Texts USE ICH Regions Test Extractable Volume Parenteral Preparations General Chapter

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ICH Topic Q 1 R2 Stability Testing NEW Drug Substances AND Products

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Guideline Plasma Derived Medicinal Products

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ICH Topic Q5B Quality Biotechnological Products Analysis Expression Construct Cell Lines Used Production R DNA Derived Protein Products

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ICH Guideline E2C R2 Periodic Benefit Risk Evaluation Report Pbrer

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Viewing AND Responding Notification Dashboard About Application Consent Import Supply OR Export Medical Devices DO NOT Meet Essential Principles

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Quality Biotechnological Products Stability Testing Biotechnologicalbiological Products

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Paediatric Addendum Chmp Guideline Clinical Investigations Medicinal Products Treatment Pulmonary Arterial Hypertension

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Guideline Clinical Trials Small Populations

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Guideline Clinical Investigation Medicinal Products Treatment Juvenile Idiopathic Arthritis

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ICH M4E R2 Common Technical Document Registration Pharmaceuticals Human USE Efficacy

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ICH Topic S 7A Safety Pharmacology Studies Human Pharmaceuticals

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Guideline Clinical Investigation Medicinal Products Treatment Duchenne AND Becker Muscular Dystrophy

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ICH M4Q Common Technical Document Registration Pharmaceuticals Human USE Quality

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Guideline Clinical Assessment Fixed Combinations Herbal Substances Herbal Preparations

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ICH E12 Principles Clinical Evaluation NEW Antihypertensive Drugs

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Guideline Clinical Investigation Medicinal Products Prevent Developmentslow Progression Chronic Renal Insufficiency

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ICH S9 QAS NON Clinical Evaluation Anticancer Pharmaceuticals Questions AND Answers Step 2B

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Guideline Clinical Evaluation Medicinal Products Indicated Prophylaxis OR Treatment Respiratory Syncytial Virus RSV Disease

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Guideline Requirements Vaccine Antigen Master File Vamf Certification

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Guideline Quality NON Clinical AND Clinical Aspects Live Recombinant Viral Vectored Vaccines

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Guideline Quality Aspects Included Product Information Vaccines Human USE Draft

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Guideline Influenza Vaccines Submission AND Procedural Requirements

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Note Guidance Development Vaccinia Virus Based Vaccines Against Smallpox

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Points Consider Wording Helicobacter Pylori Eradication Therapy Selected SPC Sections

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ICH Guideline Q4B Annex 14 Note Evaluation AND Recommendation Pharmacopoeial Texts USE ICH Regions Bacterial Endotoxins Tests General Chapter

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ICH Guideline M3 R2 Questions AND Answers

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Guideline Clinical Investigation Pharmacokinetics Therapeutic Proteins

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ICH Topic E15 Definitions Genomic Biomarkers Pharmacogenomics Pharmacogenetics Genomic Data AND Sample Coding Categories

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Points Consider Multiplicity Issues Clinical Trials

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ICH Guideline E3 Questions AND Answers R1

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ICH Guideline S2 R1 Genotoxicity Testing AND Data Interpretation Pharmaceuticals Intended Human USE

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ICH Topic S9 NON Clinical Evaluation Anticancer Pharmaceuticals

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Guideline Clinical Development Medicinal Products Treatment Cystic Fibrosis

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ICH Guideline Q4B Annex 11 Note Evaluation AND Recommendation Pharmacopoeial Texts USE ICH Regions Capillary Electrophoresis General Chapter

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Guideline NON Clinical Studies Required First Clinical USE Gene Therapy Medicinal Products

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Guideline Medicinal Gases Pharmaceutical Documentation Including Recommendation NON Clinical Safety Requirements Well Established Medicinal Gases

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Guideline Conduct Pharmacovigilance Medicines Used Paediatric Population

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Reflection Paper Pharmacogenomic Samples Testing AND Data Handling Draft

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Reflection Paper Formulations Choice Paediatric Population

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ICH Topic E 3 Structure AND Content Clinical Study Reports

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ICH Guideline S1 Regulatory Notice Changes Core Guideline Rodent Carcinogenicity Testing Pharmaceuticals

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Guideline Clinical Investigation Medicinal Products Treatment Patients Acute Respiratory Distress Syndrome

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Specifications Test Procedures AND Acceptance Criteria Herbal Substances Herbal Preparations AND Herbal Medicinal Productstraditional Herbal Medicinal Products

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Guideline NON Clinical Local Tolerance Testing Medicinal Products

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ICH Guideline S10 Photosafety Evaluation Pharmaceuticals

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ICH Guideline S6 R1 Preclinical Safety Evaluation Biotechnology Derived Pharmaceuticals

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ICH Guideline Q4B Annex 12 Note Evaluation AND Recommendation Pharmacopoeial Texts USE ICH Regions Analytical Sieving General Chapter

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ICH Guideline Q11 Development AND Manufacture Drug Substances Chemical Entities AND Biotechnological Biological Entities

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Guideline NON Clinical AND Clinical Development Medical Products Prevention Nausea AND Vomiting Associated Cancer Chemotherapy

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Guideline Validation Immunoassay Detection Antibody Human Immunodeficiency Virus Anti HIV Plasma Pools

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Guideline Replacement Rabbit Pyrogen Testing Alternative Test Plasma Derived Medicinal Products

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Guideline USE Bovine Serum Manufacture Human Biological Medicinal Products

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Concept Paper Guideline Chemical AND Pharmaceutical Quality Documentation Concerning Biological Investigational Medicinal Products Clinical Trials

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Note Guidance Pharmaceutical AND Biological Aspects Combined Vaccines

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Guideline Quality Biological Active Substances Produced Stable Transgene Expression Higher Plants

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Guideline Investigation Manufacturing Processes Plasma Derived Medicinal Products Regard Vcjd Risk

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Guideline Assessing Risk Virus Transmission NEW Chapter 6 Note Guidance Plasma Derived Medicinal Products

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Guideline Development Production Characterisation AND Specification Monoclonal Antibodies AND Related Products

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Questions AND Answers Withdrawal Guideline Pharmacokinetics AND Metabolic Studies Safety Evaluation NEW Medicinal Products Animals 3bs11a

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Guideline USE Starting Materials AND Intermediates Collected Different Sources Manufacturing NON Recombinant Biological Medicinal Products

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Completing Notification Form Lapses Medical Device Conformity Assessment Certification

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Guideline Carcinogenicity Evaluation Medicinal Products Treatment HIV Infection

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Guideline Need NON Clinical Testing Juvenile Animals Pharmaceuticals Paediatric Indications

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Guideline Evaluation Control Samples Nonclinical Safety Studies Checking Contamination Test Substance

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Guideline Repeated Dose Toxicity

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Guideline Virus Safety Evaluation Biotechnological Investigational Medicinal Products

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Guideline Real Time Release Testing Formerly Guideline Parametric Release

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Guideline Pharmaceutical Development Medicines Paediatric USE

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Guideline Scientific Data Requirements Plasma Master File PMF Revision 1

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Addendum Emachmpcvmpqwp177602009 REV 2 Defining Scope Nirs Procedure

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Guideline Quality Transdermal Patches

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Guideline Stability Testing Applications Variations Marketing Authorisation

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Guideline Quality Oral Modified Release Products

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Guideline Excipients Dossier Application Marketing Authorisation Medicinal Product

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Guideline Summary Requirements Active Substances Quality Part Dossier

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Guideline NON Clinical Development Fixed Combinations Medicinal Products

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Appendix 1 Guideline Evaluation Anticancer Medicinal Products MAN Methodological Consideration Using Progression Free Survival PFS OR Disease Free Survival DFS Confirmatory Trials

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Guideline KEY Aspects USE Pharmacogenomics Pharmacovigilance Medicinal Products

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Guideline Adjustment Baseline Covariates Clinical Trials

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Chmp SWP Conclusions AND Recommendations USE Genetically Modified Animal Models Carcinogenicity Assessment

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ICH M2 EWG Electronic Common Technical Document E CTD

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Guideline Quality Herbal Medicinal Productstraditional Herbal Medicinal Products

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ICH Guideline Q4B Annex 7 R2 Note Evaluation AND Recommendation Pharmacopoeial Texts USE ICH Regions Dissolution Test General Chapter

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Guideline Influenza Vaccines NON Clinical AND Clinical Module

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Guideline Clinical Investigation Medicinal Products Treatment Hypertension

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Comments Column Boric Acid AND Borates Annex European Commission Guideline Excipients Labelling AND Package Leaflet Medicinal Products Human USE Sante 2017 11668

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Guideline Clinical Evaluation NEW Vaccines

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Guideline Adjuvants Vaccines Human USE

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Questions AND Answers Withdrawal Note Guidance Single Dose Toxicity

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Guideline Clinical Trials Haematopoietic Growth Factors Prophylaxis Infection Following Myelosuppressive OR Myeloablative Therapy

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Guideline Xenogeneic Cell Based Medicinal Products

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Note Guidance Quality Water Pharmaceutical USE

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Guideline USE Pharmacokinetics AND Pharmacodynamics Development Antimicrobial Medicinal Products

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Questions AND Answers Ethanol Context Revision Guideline Excipients Label AND Package Leaflet Medicinal Products Human Usecpmp46300

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Guideline Clinical Investigation Medicinal Products Prevention Stroke AND Systemic Embolic Events Patients NON Valvular Atrial Fibrillation

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Reflection Paper Assessment Cardiovascular Safety Profile Medicinal Products

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Addendum Guideline Evaluation Medicinal Products Indicated Treatment Bacterial Infections

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Guideline Validation Immunoassay Detection Hepatitis B Virus Surface Antigen Hbsag Plasma Pools

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Chmp Position Statement Creutzfeldt Jakob Disease AND Plasma Derived AND Urine Derived Medicinal Products

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Guideline Allergen Products Production AND Quality Issues

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Guideline Influenza Vaccines Quality Module

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Gefitinib Film Coated Tablet 250 MG Product Specific Bioequivalence Guidance

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Development Pharmaceutics Biotechnological AND Biological Products Cpmpbwp32899 Annex Note Guidance Development Pharmaceutics Cpmpqwp15596

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Reflection Paper USE Extrapolation Development Medicines Paediatrics

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Guideline Production AND Quality Control Animal Immunoglobulins AND Immunosera Human USE

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Octreotide Acetate Depot Powder AND Solvent Suspension Injection 10 MG 20 MG AND 30 MG Product Specific Bioequivalence Guidance

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Guideline Content Management AND Archiving Clinical Master File Paper Andor Electronic

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Ezetimibe Tablet 10 MG Product Specific Bioequivalence Guidance

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Lapatinib Film Coated Tablet 250 MG Product Specific Bioequivalence Guidance Draft

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Guideline Warning Transmissible Agents Summary Product Characteristics Smpcs AND Package Leaflets Plasma Derived Medicinal Products

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Guidance Format Risk Management Plan RMP EU Integrated Format

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Interim Guidance Enhanced Safety Surveillance Seasonal Influenza Vaccines EU

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Guideline Potency Testing Cell Based Immunotherapy Medicinal Products Treatment Cancer

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Guideline Good Pharmacovigilance Practices GVP Module XV Safety Communication REV 1

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Guideline Clinical Investigation Medicinal Products Treatment Parkinsons Disease

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Points Consider Calculation AND Reporting Prevalence Condition Orphan Designation

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Guideline Missing Data Confirmatory Clinical Trials

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Guideline Evaluation Pharmacokinetics Medicinal Products Patients Impaired Hepatic Function

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ICH Guideline E14 Clinical Evaluation Qtqtc Interval Prolongation AND Proarrhythmic Potential NON Antiarrhythmic Drugs R3 Questions AND Answers

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ICH Guideline Q4B Annex 4C Evaluation AND Recommendation Pharmacopoeial Texts USE ICH Regions Acceptance Criteria Pharmaceutical Preparations AND Substances Pharmaceutical USE

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ICH Guideline Q4B Annex 5 Evaluation AND Recommendation Pharmacopoeial Texts USE ICH Regions Disintegration Test General Chapter

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Guideline USE Pharmacogenetic Methodologies Pharmacokinetic Evaluation Medicinal Products

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Guideline Clinical Investigation Medicinal Products Including Depot Preparations Treatment Schizophrenia

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Guideline Human Cell Based Medicinal Products

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Guideline Clinical Investigation Medicinal Products Treatment Venous Thromboembolic Disease

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Guideline Similar Biological Medicinal Products

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Points Consider Application 1 Meta Analyses 2 ONE Pivotal Study